EDURANT 25 mg Film-Coated Tablets

Зміст інструкції

1. EDURANT 25 mg film-coated tablets
   1. What is EDURANT and what is it used for
   2. What you need to know before taking EDURANT
   3. How to take EDURANT
   4. Possible side effects
   5. How to store EDURANT
   6. Package contents and other information
2. EDURANT 2.5 mg dispersible tablets
   1. What is EDURANT and what it is used for
   2. What you need to know before taking EDURANT
   3. How to take EDURANT
   4. Possible side effects
   5. How to store EDURANT
   6. Package contents and other information

EDURANT 25 mg film-coated tablets

rilpivirine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What EDURANT is and what it is used for
• 2. What you need to know before you take EDURANT
• 3. How to take EDURANT
• 4. Possible side effects
• 5. How to store EDURANT
• 6. Contents of the pack and other information

1. What is EDURANT and what is it used for

EDURANT contains rilpivirine which is used for the treatment of infection from the human immunodeficiency virus (Human Immunodeficiency Virus,HIV). It belongs to a group of medicines against HIV infection called non-nucleoside reverse transcriptase inhibitors (Non-Nucleoside Reverse Transcriptase Inhibitors,NNRTI). EDURANT works by reducing the amount of HIV present in the body.

• EDURANT is used in association with other medicines against HIV infectionfor the treatment of adults, adolescents and children weighing at least 25 kg with HIV infection.

The doctor will discuss with you which association of medicines is best for you.

2. What you need to know before taking EDURANT

Do not take EDURANTif you are allergic to rilpivirine or any of the other ingredients of this medicine (listed in section 6).

Do not take EDURANT in combination with any of the following medicinesas they may affect the action of EDURANT or other medicines:

• carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines used to treat epilepsy and prevent seizures)
• rifampicin and rifapentine (medicines used to treat some bacterial infections, such as tuberculosis)
• omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors - these are medicines to prevent and treat stomach ulcers, heartburn or acid reflux disease).
• dexamethasone (a corticosteroid used in various clinical conditions such as inflammation and allergic reactions); if taken orally or by injection, except as a single dose
• products containing St John's Wort (Hypericum perforatum) (a herbal remedy used to treat depression).

If you are taking any of these medicines, speak to your doctor for alternatives.

Warnings and precautions
Talk to your doctor or pharmacist before taking EDURANT.
EDURANT is not a cure for HIV infection. It is part of a treatment that reduces the amount of virus in the blood.
EDURANT has only been given to a limited number of patients aged 65 years or older. If you belong to this age group, discuss the use of EDURANT with your doctor.

Tell your doctor about your condition
Make sure you check the following points and tell your doctor if any of them apply to you.

• Tell your doctor if you have or have suffered from liver problems,including hepatitis B and/or C, and/or kidney problems. Your doctor can assess the severity of your liver or kidney disease before deciding whether to give you EDURANT.
• Immediately tell your doctor if you notice any symptoms of infection(for example, fever, chills, sweating). In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of previous infections may appear shortly after starting treatment for HIV infection. These symptoms are thought to be due to an improvement in the body's immune response, which allows it to fight infections that may have been present without clear symptoms.
• In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks the body's healthy tissue) may also occur after you have started taking medicines to treat HIV infection. Autoimmune disorders can occur many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, initial weakness in hands and feet that rises towards the torso, palpitations, tremor or hyperactivity, tell your doctor immediately to request the necessary treatment.
• Tell your doctor if you are taking medicines that can cause a dangerous, life-threatening irregular heartbeat (Torsade de Pointes).

Children
EDURANT is not indicated for the treatment of children under 2 years of age or weighing less than
14 kg, as it has not been evaluated in these patients.

Other medicines and EDURANT
You can take EDURANT together with other medicines against HIV infection. Your doctor will tell you
which HIV medicines you can combine with EDURANT and together you will decide
which combination is most suitable for your needs. Follow your doctor's instructions carefully.
Some medicines may affect the levels of EDURANT in the blood if taken
at the same time.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.

It is not recommended to combine EDURANT withother non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as delavirdine, efavirenz, etravirine and nevirapine.

The effect of EDURANT or other medicines may be affected,if you take EDURANT
together with the following medicines. Tell your doctor if you are taking:

• rifabutin (a medicine used to treat some bacterial infections). If you are taking this medicine while taking EDURANT, read carefully how to take EDURANT in section 3 “Instructions for correct use in adults and adolescents (12 to 18 years of age)”.
• clarithromycin, erythromycin (antibiotics)
• cimetidine, famotidine, nizatidine, ranitidine (histamine H2 receptor antagonists used to treat stomach or intestinal ulcers or to relieve heartburn due to acid reflux). If you are taking other medicines, read carefully how to take them in section 3 “Instructions for correct use in adults and adolescents (12 to 18 years of age)”.
• antacids (used to treat diseases related to the presence of gastric juices in the stomach; for example, aluminum/magnesium hydroxide, calcium carbonate). If you are taking other medicines, read carefully how to take them in section 3 “Instructions for correct use in adults and adolescents (12 to 18 years of age)”.
• methadone (used for the treatment of narcotic withdrawal and for dependencies)
• dabigatran etexilate (anticoagulant). Tell your doctor if you are taking any of the medicines listed above.

Pregnancy and breastfeeding
Tell your doctor immediately if you are pregnant or planning a pregnancy: pregnant women
should discuss the use of EDURANT with their doctor.
Breastfeeding is not recommended in women with HIV because HIV infection can
be transmitted to the baby through breast milk.
If you are breastfeeding or planning to do so, it is good to talk to your doctor as soon as possible.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Some patients may experience fatigue, dizziness or drowsiness during treatment with
EDURANT. Do not drive or use machines if you feel tired, dizzy or drowsy
while taking EDURANT.

EDURANT contains lactose
If your doctor has told you that you are intolerant to some sugars, consult your doctor before taking
this medicine.

EDURANT contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means that it is
essentially “sodium-free”.

3. How to take EDURANT

Take EDURANT exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.

Instructions for correct use in adults, adolescents and children (weighing at
least 25 kg)
EDURANT is also available as dispersible tablets for pediatric patients aged between
2 and less than 18 years weighing at least 14 kg and less than 25 kg ( see separate
instructions for use).Film-coated tablets and dispersible tablets are not equivalent. Do not
replace the 25 mg film-coated tablet with ten 2.5 mg dispersible tablets.
The recommended dose of EDURANT is one tablet once a day.
EDURANT must be taken with a meal. The meal is important to ensure that the correct levels of active
ingredient are present in the body. A nutritional drink alone (e.g. protein-rich) does not replace a meal.
There are four situations that require particular attention:

• 1. If you are taking rifabutin(a medicine to treat some bacterial infections), take two EDURANT tablets once a day. When you stop taking rifabutin, take one EDURANT tablet once a day. Ask your doctor or pharmacist if you are not sure.
• 2. If you are taking an antacid(medicine used to treat diseases related to the presence of gastric juices in the stomach, such as aluminium/magnesium hydroxide, calcium carbonate). Take the antacid at least 2 hours before or 4 hours after taking EDURANT (see section 2, “Other medicines and EDURANT”).
• 3. If you are taking an H receptor antagonist(medicines used to treat gastric or intestinal ulcers or to relieve heartburn due to gastric juice reflux such as cimetidine, famotidine, nizatidine or ranitidine). Take the H receptor antagonist at least 12 hours before or 4 hours after taking EDURANT (see section 2, “Other medicines and EDURANT”). H receptor antagonists should not be taken with a dosage regimen that provides for the administration of the medicine twice a day. Consult your doctor for an alternative regimen.
• 4. If you are taking didanosine(a medicine for the treatment of HIV infection), no dose adjustment is necessary. Didanosine must be administered on an empty stomach at least two hours before or at least four hours after EDURANT (which must be taken with a meal).

Removal of child-resistant closure.

The bottle is equipped with a child-resistant closure, to be opened by pressing down on the
screw cap and rotating it simultaneously in an anti-clockwise direction.

If you take more EDURANT than you should
Contact your doctor or pharmacist immediately. In case of overdose, you may experience headache, nausea,
dizziness, and/or abnormal dreams.

If you forget to take EDURANT
If you remember within 12 hours of the time you usually take EDURANT,you should take the
tablet as soon as possible. The EDURANT tablet must be taken with a meal. Then take
your next dose as usual. If you remember after 12 hours, do not take that dose and
take your next dose as usual. Do not take a double dose to make up for a forgotten dose.
If you vomit within 4 hours of taking EDURANT, take another tablet with a meal. If
you vomit more than 4 hours after taking EDURANT, you do not need to take another tablet
until your next regularly scheduled tablet.
Contact your doctor if you are not sure what to do when you forget a dose or vomit.

Do not stop taking EDURANT
Treatment for HIV is not curative for HIV infection! Do not stop treatment with
EDURANT without first consulting your doctor. Even if you feel better, do not stop taking
EDURANT or other HIV medicines. Otherwise, you may increase the risk that the virus
develops resistance. Talk to your doctor first.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):

• headache
• nausea
• difficulty falling asleep (insomnia)
• feeling dizzy
• changes in one of the routine liver tests (transaminases)
• increased cholesterol and/or pancreatic amylase in the blood

Common (may affect up to 1 in 10 people):

• abnormal dreams
• skin rash
• stomach pain
• depression
• feeling very tired
• vomiting
• feeling drowsy
• loss of appetite
• sleep disorders
• stomach discomfort
• feeling depressed
• dry mouth
• low white blood cell and/or platelet count, decreased hemoglobin levels in the blood, increased levels of triglycerides, lipase and/or bilirubin in the blood

Uncommon (may affect up to 1 in 100 people):

• signs or symptoms of inflammation or infection, for example fever, chills, sweating (immune reconstitution syndrome).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the
national reporting system listed in Annex V.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store EDURANT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer packaging and on the
bottle after the wording Exp. The expiry date refers to the last day of the month indicated.
Store in the original bottle, to protect the medicine from light. This medicine does not
require any particular storage temperature.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What EDURANT contains

• The active ingredient is rilpivirine in the form of rilpivirine hydrochloride. Each EDURANT tablet contains rilpivirine hydrochloride equivalent to 25 mg of rilpivirine.
• The other components of the tablet core coated with a film are lactose monohydrate, sodium croscarmellose (E468), povidone K30 (E1201), polysorbate 20, microcrystalline cellulose silicified (E460) and magnesium stearate (E470b). The film coating contains lactose monohydrate, hypromellose 2910 6 mPa.s (E464), titanium dioxide (E171), macrogol 3000 and triacetin (E1518).

Description of the appearance of EDURANT and package contents
Round, biconvex tablet of white to off-white color, film-coated, with
the inscription “TMC” on one side and “25” on the other.
Bottle with a child-resistant closure containing 30 film-coated tablets.

Marketing Authorization Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen-Cilag SpA.
Via C. Janssen
Borgo San Michele
04100 Latina
Italy
For further information on this medicinal product, contact the local representative of the marketing
authorization holder:

België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: +32 14 64 94 11
[email protected]

Lietuva
UAB “JOHNSON & JOHNSON”
Tel: +370 5 278 68 88
[email protected]

България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00
[email protected]

Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: +32 14 64 94 11
[email protected]

Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227

Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858
[email protected]

Danmark
Janssen-Cilag A/S
Tlf.: +45 4594 8282
[email protected]

Malta
AM MANGION LTD.
Tel: +356 2397 6000

Deutschland
Janssen-Cilag GmbH
Tel: 0800 086 9247 / +49 2137 955 6955
[email protected]

Nederland
Janssen-Cilag B.V.
Tel: +31 76 711 1111
[email protected]

Eesti
UAB “JOHNSON & JOHNSON” Eesti filiaal
Tel: +372 617 7410
[email protected]

Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00
[email protected]

Ελλάδα
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη
Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000

Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300

España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00
[email protected]

Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: +48 22 237 60 00

France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
[email protected]

Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600

Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700
[email protected]

România
Johnson & Johnson România SRL
Tel: +40 21 207 1800

Ireland
Janssen Sciences Ireland UC
Tel: 1 800 709 122
[email protected]

Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
[email protected]

Ísland
Janssen-Cilag AB
c/o Vistor hf.
Sími: +354 535 7000
[email protected]

Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400

Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1
[email protected]

Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
[email protected]

Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ,
Τηλ: +357 22 207 700

Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00
[email protected]

Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561
[email protected]

United Kingdom (Northern Ireland)
Janssen Sciences Ireland UC
Tel: +44 1 494 567 444
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: https://www.ema.europa.eu.

EDURANT 2.5 mg dispersible tablets

rilpivirina

Read this leaflet carefully before taking this medicine (or giving it to your child) as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you (or your child) only. Do not pass it on to others, even if they have the same symptoms as you (or your child), as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

we simply use “you”.

Contents of this leaflet:

• 1. What EDURANT is and what it is used for
• 2. What you need to know before you take EDURANT
• 3. How to take EDURANT
• 4. Possible side effects
• 5. How to store EDURANT
• 6. Contents of the pack and other information

1. What is EDURANT and what it is used for

EDURANT contains “rilpivirine” which is used for the treatment of infection by the human immunodeficiency virus (Human Immunodeficiency Virus,HIV). It belongs to a group of medicines against HIV infection called non-nucleoside reverse transcriptase inhibitors (Non-Nucleoside Reverse Transcriptase Inhibitors,NNRTI). EDURANT works by reducing the amount of HIV present in the body.

EDURANT is used in combination with other medicines against HIV infectionfor the treatment of children and adolescents aged between 2 and less than 18 years who weigh at least 14 kg and less than 25 kg with HIV infection.
The doctor will explain which combination of medicines is best for you.

2. What you need to know before taking EDURANT

Do not take EDURANTif you are allergic to rilpivirine or any of the other ingredients of this medicine (listed in section 6).

Do not take EDURANT in combination with any of the following medicinesas they may affect the action of EDURANT or other medicines:

• carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines to treat epilepsy and prevent seizures)
• rifampicin and rifapentine (medicines for the treatment of some bacterial infections, such as tuberculosis)
• omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors - these are medicines to prevent and treat stomach ulcers, heartburn or acid reflux disease).
• dexamethasone (a corticosteroid used in various clinical conditions such as inflammation and allergic reactions); if taken orally or by injection, except as a single dose
• products containing St John's Wort (a herbal remedy used to treat depression).

Do not take EDURANT if you are taking any of these medicines. If you are unsure, ask your doctor or pharmacist before taking EDURANT. Ask your doctor about possible alternatives to the medicines listed above.

Warnings and precautions
Talk to your doctor or pharmacist before starting to take EDURANT.
EDURANT is not a cure for HIV infection. It is part of a treatment that reduces the amount of virus present in the blood.

Tell your doctor about your condition
Make sure you check the following points and tell your doctor if any of them apply to you.

• Tell your doctor if you have or have suffered from liver problems,including hepatitis B and/or C, and/or kidney problems. Your doctor may assess the severity of your liver or kidney disease before deciding whether to give you EDURANT.
• Immediately tell your doctor if you notice any symptoms of infection(for example, fever, chills, sweating). In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of previous infections may appear shortly after starting treatment for HIV infection. These symptoms are thought to be due to an improvement in the body's immune response, which allows it to fight infections that may have been present without clear symptoms.
• In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy tissue in the body) may also occur after you have started taking medicines to treat HIV infection. Autoimmune disorders can occur many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, initial weakness in the hands and feet that rises towards the torso, palpitations, tremor or hyperactivity, tell your doctor immediately to request the necessary treatment.
• Tell your doctor if you are taking medicines that can cause a dangerous, life-threatening irregular heartbeat (Torsade de Pointes).

Children
Do not use EDURANT for the treatment of children under 2 years of age or weighing less than 14 kg, as it has not been evaluated in these patients.

Other medicines and EDURANT
You can take EDURANT together with other medicines against HIV infection. Your doctor will tell you which HIV medicines you can take with EDURANT and together you will decide which combination is most suitable for your needs. You must carefully follow your doctor's instructions.
Some medicines may affect the levels of EDURANT in the blood if taken at the same time.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is not recommended to combine EDURANT withother non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as delavirdine, efavirenz, etravirine and nevirapine.

The effect of EDURANT or other medicines may be affected,if you take EDURANT together with the following medicines. Tell your doctor if you are taking:

• antibiotics such as clarithromycin, erythromycin
• cimetidine, famotidine, nizatidine, ranitidine (histamine H2 receptor antagonists used to treat stomach or intestinal ulcers or to relieve heartburn due to acid reflux). If you are taking other medicines, read carefully how to take them in section 3
• antacids (used to treat diseases related to the presence of gastric juices in the stomach; for example, aluminum/magnesium hydroxide, calcium carbonate). If you are taking other medicines, read carefully how to take them in section 3
• methadone (used for the treatment of narcotic withdrawal and dependencies)
• dabigatran etexilate (anticoagulant). Tell your doctor if you are taking any of the medicines listed above.

Pregnancy and breastfeeding
Tell your doctor immediately if you are pregnant or planning a pregnancy: pregnant women should discuss the use of EDURANT with their doctor.
Breastfeeding is not recommended for women infected with HIV because HIV infection can be transmitted to the baby through breast milk.
If you are breastfeeding or planning to do so, it is best to talk to your doctor as soon as possible.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machines
Some patients may experience fatigue, dizziness or drowsiness during treatment with EDURANT. Do not drive any type of vehicle or use tools or machinery if you feel tired, dizzy or drowsy while taking EDURANT.

EDURANT contains lactose and sodium
This medicine contains lactose. If your doctor has told you that you are intolerant to some sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially “sodium-free”.

3. How to take EDURANT

Take EDURANT exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist. Your doctor or pharmacist will tell you how many dispersible tablets of EDURANT you need to take. EDURANT dispersible tablets must be dispersed in
water and taken with a meal.

• EDURANT is also available as film-coated tablets for paediatric and adult patients with a body weight of at least 25 kg (see separate package leaflet). Film-coated tablets and dispersible tablets are not equivalent. Do not substitute a 25 mg film-coated tablet with ten 2.5 mg dispersible tablets.

Instructions for use
Edurant dispersible tablets must be taken with a meal.The meal is important to ensure that
the correct levels of the medicine are present in the body. A nutritional drink alone (such
as a protein shake) or yogurt does not replace a meal.
Prepare and take EDURANT dispersible tablets every day exactly as instructed
by your doctor. Read these instructions carefully before taking EDURANT dispersible
tablets. Your doctor will tell you how many dispersible tablets of EDURANT you need to take, based
on your weight. EDURANT dispersible tablets must be dispersed in water. You must not
chew the tablets or swallow them whole.

Step 1: prepare the medicine

• Count the number of tablets needed and tear each unit from the blister pack along the dotted line.
• Do not push the tablets to make them come out of the foil because they may break.
• For each unit, gently peel off the aluminium following the direction of the arrow.

Step 2: put the tablets in a cup

• Gently place the tablets in a cup. Do not crush the tablets.
• Add 5 ml (1 teaspoonful) of water at room temperature to the cup.
• Stir carefully to disperse the tablets. The mixture will start to look cloudy.

If you spill any of the medicine, clean up the spill. Throw
away the remaining prepared medicine and prepare a new
dose.
You must take the dose of medicine immediately.If you do not
take the medicine immediately, throw away the mixture and
prepare a new dose of medicine.

Step 3: take the medicine

• Take the prepared medicine immediately or add another 5 ml (1 teaspoonful) of water or one of the following substances at room temperature to help with administration: milk, orange juice or applesauce.
• Stir and take the medicine immediately. You can use a spoon if necessary.
• Make sure you have taken the entire dose and that there is no medicine left in the cup. If necessary, add another 5 ml (1 teaspoonful) of water or the same drink (milk, orange juice) or applesauce; stir and drink immediately.

There are three situations that require particular attention. If you are taking:

• 1. an antacid(medicine used to treat diseases related to the presence of gastric juices in the stomach, such as aluminium/magnesium hydroxide, calcium carbonate). Take the antacid:
• at least 2 hours before or
• at least 4 hours after taking EDURANT (see section 2, “Other medicines and EDURANT”).
• 2. an H receptor antagonist(medicines used to treat stomach or intestinal ulcers or to relieve heartburn due to acid reflux such as cimetidine, famotidine, nizatidine or ranitidine). Take the H receptor antagonist
• at least 12 hours before or
• at least 4 hours after taking EDURANT (see section 2, “Other medicines and EDURANT”). H2 receptor antagonists should not be taken with a dosing regimen that provides for twice-daily administration. Consult your doctor for an alternative regimen.

• 3. didanosine(a medicine for the treatment of HIV infection), no dose adjustment is necessary. Didanosine must be administered on an empty stomach
• at least two hours before or
• at least four hours after EDURANT (which must be taken with a meal).

If you take more EDURANT than you should
Contact your doctor or pharmacist immediately. In case of an overdose, you may experience headache, nausea,
dizziness, and/or abnormal dreams.

If you forget to take EDURANT
If you realise within 12 hours of the time you usually take EDURANT,you should take the
dose as soon as possible. EDURANT tablets must be taken with a meal. Then take
the next dose as usual. If you realise after 12 hours, do not take that dose and take the
next dose as usual. Do not take a double dose to make up for a missed dose.
Contact your doctor if you are unsure what to do when you have missed a dose.

If you vomit after taking EDURANT
If you vomit within 4 hours after taking EDURANT, take another dose with a meal. If you vomit more
than 4 hours after taking EDURANT, you do not need to take another dose until your next
scheduled dose.
Contact your doctor if you are unsure what to do when you vomit after taking this medicine.

Do not stop taking EDURANT
Treatment for HIV is not curative for HIV infection! Do not stop taking EDURANT without first talking to your doctor. Even if you feel better, do not stop EDURANT or
your other HIV medicines. Otherwise, the risk that the virus develops resistance may increase. Talk to your doctor before stopping this medicine.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people)::

• headache
• nausea
• difficulty falling asleep (insomnia)
• feeling dizzy
• changes in one of the routine liver tests (transaminases)
• increased cholesterol and/or pancreatic amylase in the blood

Common (may affect up to 1 in 10 people):

• abnormal dreams
• skin rash
• stomach pain
• depression
• feeling very tired
• vomiting
• feeling sleepy
• loss of appetite
• sleep disorders
• stomach discomfort
• feeling down
• dry mouth
• low white blood cell and/or platelet count, decreased hemoglobin levels in the blood, increased levels of triglycerides, lipase and/or bilirubin in the blood

Uncommon (may affect up to 1 in 100):

• signs or symptoms of inflammation or infection, for example fever, chills, sweating (immune reconstitution syndrome).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the
national reporting system listed in Annex V.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store EDURANT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer packaging and on the
blister after the wording Exp. The expiry date refers to the last day of the month indicated.
Store in the original package, to protect the medicine from light and moisture. This
medicine does not require any particular storage temperature.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What EDURANT contains

• The active ingredient is “rilpivirine” in the form of “rilpivirine hydrochloride”. Each dispersible tablet of EDURANT contains rilpivirine hydrochloride equivalent to 2.5 mg of rilpivirine.
• The other components of the tablet core are sodium croscarmellose (E468), lactose monohydrate, mannitol (E421), microcrystalline cellulose (E460), polysorbate 20, povidone K30 (E1201), sodium lauryl sulfate (E487) and sodium stearyl fumarate.

Description of the appearance of EDURANT and package contents
Round-shaped tablet, 6.5 mm, and in color from white to almost white, with “TMC” inscribed on one
side and “PED” on the other.
EDURANT 2.5 dispersible tablets are available in perforated Alu-Alu blisters for unit dose with
integrated desiccant and a tear-off aluminum cover.
Each child-resistant blister contains 10 x 1 dispersible tablets. Each box contains 90 x 1
dispersible tablets.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen-Cilag SpA.
Via C. Janssen
Borgo San Michele
04100 Latina
Italy
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: +32 14 64 94 11
[email protected]

Lietuva
UAB “JOHNSON & JOHNSON”
Tel: +370 5 278 68 88
[email protected]

България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00
[email protected]

Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: +32 14 64 94 11
[email protected]

Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227

Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858
[email protected]

Danmark
Janssen-Cilag A/S
Tlf.: +45 4594 8282
[email protected]

Malta
AM MANGION LTD.
Tel: +356 2397 6000

Deutschland
Janssen-Cilag GmbH
Tel: 0800 086 9247 / +49 2137 955 6955
[email protected]

Nederland
Janssen-Cilag B.V.
Tel: +31 76 711 1111
[email protected]

Eesti
UAB “JOHNSON & JOHNSON” Eesti filiaal
Tel: +372 617 7410
[email protected]

Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00
[email protected]

Ελλάδα
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη
Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000

Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300

España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00
[email protected]

Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: +48 22 237 60 00

France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
[email protected]

Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600

Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700
[email protected]

România
Johnson & Johnson România SRL
Tel: +40 21 207 1800

Ireland
Janssen Sciences Ireland UC
Tel: 1 800 709 122
[email protected]

Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
[email protected]

Ísland
Janssen-Cilag AB
c/o Vistor hf.
Sími: +354 535 7000
[email protected]

Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400

Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1
[email protected]

Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
[email protected]

Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ,
Τηλ: +357 22 207 700

Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00
[email protected]

Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561
[email protected]

United Kingdom (Northern Ireland)
Janssen Sciences Ireland UC
Tel: +44 1 494 567 444
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: https://www.ema.europa.eu.